Contact lens manipulator with suction cup and safety release mechanism

ABSTRACT

A lens manipulator that includes an over-sleeve with a suction cup and lumen therethrough that forms a pore in the suction cup and a rod opening at the opposite end for receiving an adjustment rod. Adjustment of the length of the adjustment rod in the lumen controls the amount of suction force generated under the suction cup against a contact lens. Removal of the adjustment rod from the lumen eliminates the suction force and acts as a safety release against excessive pull force on an eye when removing a contact lens.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/329,380, filed Feb. 28, 2019, now U.S. Pat. No. 10,765,553, which isthe U.S. national stage application of International patent applicationNo. PCT/US2017/049067, filed Aug. 29, 2017, which claims the benefit ofU.S. Provisional Application Ser. No. 62/537,507, filed Jul. 27, 2017,U.S. Provisional Application Ser. No. 62/450,789, filed Jan. 26, 2017,and U.S. Provisional Application Ser. No. 62/381,007, filed Aug. 29,2016, the disclosures of which are hereby incorporated by reference intheir entireties, including all Figures, tables and drawings.

BACKGROUND OF INVENTION

Contact lens wearers usually insert and remove their contact lensesmanually. With Rigid Gas Permeable (RGP) and the new hybrid contactlenses this task can be more complicated. Hybrid lenses are designed tocorrect atypical vision problems and have irregular thicknesses, often arigid central zone and softer peripheral zone. These types ofspecialized contact lenses are often larger in diameter and can form astronger adherence to the eye surface, which can make them difficult toremove. Inserting and removing contact lenses can have other ergonomiclimitations, given that it is a maneuver that typically requires manualdexterity, coordination, and stability. People for whom inserting andremoving RGP and hybrid contact lenses with their fingers can be adifficult task includes seniors, children, superior-limb handicappedindividuals, those with long fingernails, or anyone lacking thenecessary manual dexterity or stability.

A variety of lens manipulators with suction cups have been developed tomanipulate specialized contact lenses, but many are not equallyeffective for both insertion and removal of a contact lens. If thesuction cup of the lens manipulator can provide sufficient suction oncontact with the contact lens to facilitate removal, that same force maynot release the contact lens when the suction cup is retracted.Likewise, if suction or adherence is sufficient to facilitate insertionand easy release, then the suction cup may not exert sufficient suctionto be effective for removal.

Some lens manipulators utilize suction cups that rely on “passive”vacuum force, wherein the vacuum force in the cup depends upon thevolume of air displacement under the concave surface of the suction cup.Air displacement can be accomplished by either pressing the suction cuponto a surface to compress the suction cup, or by pressing/releasing aflexible or pliant bulb attached to the suction cup. Either methodresults in a decrease in pressure under the suction cup. Thesetechniques, usually manually controlled, may not provide sufficientcontrol over the vacuum force that the cup can exert on the contact lensand the eye. Thus, the amount of pressure under the suction cup cannotbe precisely or consistently regulated. Further, if the contact lens isstuck to the eye and cannot be removed normally, it can be difficult todisengage the already attached suction cup from the contact lens.

Other lens manipulators for contact lens insertion and extraction canprovide “active” vacuum or positive pressure with the use of a pump,such as, for example, the CLIARA device disclosed in U.S. PublishedApplication No. 2015/0265467. These types of devices can requirespecific configurations of suction cups to facilitate the formation andrelease of vacuum force within the cup.

Surface tension, Van der Waal's forces, hydrophilic/hydrophobicinteractions, and other factors can affect the surface interactionbetween the contact lens and the suction cup. Certain materials, surfacefinishes, textures, additives or coatings, and other substances can makethe suction cup surface “sticky,” causing it to adhere to the lenssurface, independent of the vacuum pressure. A suction cup with a“sticky” surface can be beneficial for contact lens extraction, butinhibit contact lens insertion by not releasing the lens once engagedwith the eye. The opposite can also be true, where a non-sticky surfacecan be beneficial for insertion, but can inhibit extraction.

There is a need for a suction cup that addresses the limitations ofpreviously known suction cups on such devices, with regard to insertionand removal of contact lenses. Ideally, such a suction cup can be usedwith a lens manipulator that can aid in inserting and removing contactlenses with more control over the amount of suction force. Such a devicecan, ideally, reduce the amount of manual dexterity and coordinationrequired to remove and insert specialized contact lenses, and inhibitsundesirable contact with the cornea or sclera of the eye. It can also beadvantageous if the device can be released by a user through activationof a quick-release mechanism or to release the contact lensautomatically if excessive extraction force is applied to the contactlens.

BRIEF SUMMARY

In accordance with the invention, the problem of handling a contact lensfor depositing and extracting from the surface of an eye is solved by alens manipulator with a suction cup in which the suction force can beaccurately adjusted or customized to an individual. The advantageousability to adjust the amount of suction force exerted by the suction cupof the lens manipulator can facilitate release of the contact lens byinhibiting the suction cup from remaining attached to the contact lensduring an insertion procedure. The lens manipulator can also have theability to fully release the suction force exerted by the suction cup,often during an extraction procedure, if excessive pulling force isapplied to the suction cup. This feature enables the suction cup tosafely release from a contact lens that is too firmly attached to theeye, mitigating the risk of injury. The lens manipulator can also bereleased voluntarily by the user at any time if desired.

Suction cups typically have a conical, semi-circular, or similarlyconcave shape and are made of a malleable material that can flatten whenthe concave side is pushed towards an object and usually biased toreturn to the original shape. The suction force generated by a suctioncup is dependent upon both the difference in air pressure between theoutside and inside of the cup and the surface area under the cup. Ifeither one of these factors is increased or decreased, it can affect theamount of suction force produced by the suction cup.

When the suction cup engages with the contact lens before it isdeposited on the eye, the formation of even a small |_([O1])attractionforce between the suction cup and the contact lens can make it difficultfor the contact lens to disengage from the suction cup and remain on theeye. Also disclosed herein are embodiments of a suction cup with adiscontinuous peripheral edge. The discontinuous peripheral edge cansupport the contact lens while preventing the formation of a continuousseal with the lens surface. This minimizes the formation of a suctionforce that would inhibit a contact lens to be inserted on the eye. Whenan intentional force is applied, such as when a contact lens is to beextracted, the discontinuous peripheral edge can flattened or radiallydeflected as the suction cup is pushed onto the contact lens, so that acontinuous edge 80 on the suction cup is exposed or made available tomake sealing contact with the contact lens, allowing formation of vacuumunder the suction cup. In one embodiment, the suction cup can beattached to a stem that can be used to manipulate the suction cup.

Some contact lenses can be more easily extracted when the extractionforce is applied eccentrically. With eccentric extraction the suctioncup engages the contact lens surface off-center. Engaging the contactlens off-center can necessitate that a suction cup attached to a stem beable to bend, rotate, or otherwise adjust position relative to the stem,so that the leading edge can make full contact with the lens.Embodiments of the subject invention provide a flexible stem that allowsthe suction cup to be engaged in an eccentric manner with the contactlens.

Deposition of a contact lens on the cornea typically does not requirethe application of force to the cornea. The fluid reservoir or concavesurface of the contact lens can be filled with an appropriate fluid,such as sterile saline solution, which can provide sufficient surfacetension and adhesion to pull the contact lens onto the corneal surfacewhen the contact lens is brought into proximity with the eye. Extractionof a contact lens can be problematic if there is stronger than usualattraction forces between the eye and the contact lens. If a suction cupapplied to the convex surface of the contact lens forms stronger thanusual or stronger than necessary attractive forces, a suction cup maynot pull off or disengage from the contact lens.

Embodiments of the subject invention provide an advantageous safetymechanism by which the suction cup can be easily disengaged from theconvex surface of the contact lens with minimal or no application ofpull force on the eye. The safety mechanism can release the vacuumbetween the suction cup and a contact lens, causing the suction cup todisengage from the surface of the contact lens. The application ofmedicines, drugs, pharmaceutical compositions, and other substances ormaterials to the eye can also be problematic. Embodiments of the subjectinvention can be used as applicators for such substances andmedicaments. The suction cup can be filed with the substance and appliedto the eye. Alternatively, a contact lens can be employed as anintermediate applicator between the suction cup and the eye.

In one general embodiment, a lens manipulator has an over-sleeve with asuction cup at the proximal end of a stem 210 and a lumen through atleast some portion of, or the full, longitudinal length. At the proximalend, the lumen terminates in a pore that opens into the suction cup. Thedistal end of the lumen can be placed over an adjustment rod or,alternatively, a plug with a nipple. The combination of the lumen andthe adjustment rod or plug therein provides control over the amount ofsuction strength that can be formed under the suction cup. By moving theadjustment rod into or out of the lumen, the air pressure that can begenerated under the suction cup can be increased or decreased, asneeded. Advantageously, if the rod or plug is removed from the lumen,such that ambient air can intrude through the lumen, the force under thesuction cup is entirely released. This can inhibit excessive or damagingpull force being applied to a contact lens that may be stuck to the eye.The over-sleeve and adjustment rod can be configured so that the rod ispulled from the lumen if a predetermined maximum amount of pulling forceis applied. Further embodiments can include a cuff that further aids inproviding friction against the over-sleeve to control movement of therod in the lumen.

When installing a contact lens on the eye, the suction cup can bedirected upwards and a contact lens can be placed on the suction cup,without the application of force that would cause the suction force tostick to the contact lens. The concavity of the contact lens can then befilled with saline or other contact lens solution or medicines or drugs,as mentioned above. Bending forward to bring the eye into proximity withthe suction cup causes the eye surface to contact the lens solution,thereby pulling the contact lens away from the suction cup and onto theeye surface.

It should be noted that this Brief Summary is provided to generallyintroduce the reader to one or more select concepts described below inthe Detailed Disclosure in a simplified form. This Summary is notintended to identify key and/or required features of the claimed subjectmatter. Other aspects and further scope of applicability of the presentinvention will also become apparent from the detailed descriptions givenherein. It should be understood, however, that the detaileddescriptions, while indicating preferred embodiments of the invention,are given by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent from such descriptions. The invention is defined by the claimsbelow.

BRIEF DESCRIPTION OF DRAWINGS

In order that a more precise understanding of the above recitedinvention can be obtained, a more particular description of theinvention briefly described above will be rendered by reference tospecific embodiments thereof that are illustrated in the appendeddrawings. The drawings presented herein may not be drawn to scale andany reference to dimensions in the drawings or the following descriptionis specific to the embodiments disclosed. Any variations of thesedimensions that will allow the subject invention to function for itsintended purpose are considered to be within the scope of the subjectinvention. Thus, understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered aslimiting in scope, the invention will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings in which:

FIG. 1 is an illustration of a lens manipulator, according to anembodiment of the subject invention.

FIG. 2 is an enlarged cut-away view, taken along line 2-2′ of the distalend of an embodiment of a lens manipulator, according to the subjectinvention. In this view, the over-sleeve is shown pulled disengaged fromthe adjustment rod.

FIG. 3A is an enlarged cut-away view, taken along line 2-2′ of thedistal end of an embodiment of a lens manipulator, according to thesubject invention. In this view, the lens manipulator is shown seated inthe friction sleeve and the adjustment rod is removed from the lumen.Also shown is an embodiment of an alignment tip.

FIG. 3B shows an alternative embodiment of an alignment tip on anadjustment rod.

FIG. 4 shows a front elevation view of an embodiment of a lensmanipulator.

FIGS. 5A, 5B, and 5C show, in a photograph, embodiments of a lensmanipulator in different stages of assembly. FIG. 5A is an embodiment ofa completely assembled lens manipulator. FIG. 5B is an embodiment of alens manipulator without the over-sleeve.

FIG. 5C is an embodiment of a lens manipulator without the suction cup.

FIG. 6 is a photograph of an embodiment of an over-sleeve.

FIG. 7 is a photograph of a lens manipulator held in a hand to show howit can be manipulated.

FIGS. 8, 9, and 10 are images of another alternative embodiment of alens manipulator, wherein the proximal end of the adjustment rod, theover-sleeve, and the cuff are turned approximately 90° relative to ahandle portion.

FIGS. 11, 12, 13, and 14 are exploded views of the alternativeembodiment in FIGS. 8, 9, and 10.

FIG. 15 is an isometric view of an embodiment of a suction cup with aninterrupted or discontinuous leading edge, according to embodiments ofthe subject invention.

FIG. 16 is an isometric view of an embodiment of a suction cup with aleading edge having a surface texture and holes or vents, according toembodiments of the subject invention.

FIG. 17 is an isometric view of an embodiment of a suction cup withflexible neck, according to embodiments of the subject invention.

FIGS. 18A and 18B are an isometric view and a side view, respectively,of an embodiment of a suction cup with ribs, according to embodiments ofthe subject invention.

FIG. 18B illustrates how the radial ribs can cause an uneven pullingforce on the suction cup forming a pucker or fold in the contact torelease suction.

FIGS. 19A and 19B are representative views of a contact lens placed onan embodiment of a suction cup device, according to the subjectinvention. FIG. 19A shows a contact lens on a discontinuous peripheraledge and FIG. 19B shows the discontinuous peripheral edge deflected andthe contact lens in contact with the continuous edge.

FIG. 20 is a photograph of an embodiment of a suction cup having asafety mechanism, according to the subject invention.

FIG. 21 is a photograph of an embodiment of a suction cup having asafety mechanism with an incorporated guide, according to the subjectinvention.

FIG. 22 illustrates an embodiment of an over-sleeve with a safetymechanism operably connected to a pump of a lens manipulator.

FIGS. 23A and 23B show an alternative embodiment of a lens manipulatorthat incorporates a plunger with the cuff.

DETAILED DISCLOSURE

The subject invention pertains to devices and methods for inserting andremoving a contact lens from the surface of an eye. More specifically,the subject invention provides one or more embodiments of a lensmanipulator for use in handling Rigid Gas Permeable (RGP) and Hybridcontact lenses for insertion or removal from the surface of an eye. Lensmanipulator embodiments of the subject invention employ a suction cup tohold a contact lens. Advantageously, the amount of suction force exertedonto a contact lens by a lens manipulator of the subject invention canbe adjusted. If the maximum pulling force of the lens manipulator isinsufficient to remove a contact lens, a safety release mechanism caninhibit the application of excessive pulling force on the eye whenextracting a contact lens. The safety release mechanism can be activatedautomatically during use or, if necessary, intentionally by a user torelease the suction cup from a contact lens. While embodiments of thesubject invention are particularly useful with Rigid Gas Permeable (RGP)and newer hybrid lenses, a person with skill in the art will recognizeembodiments that can be utilized with other types of contact lenses.

The terms “contact” and “contact lens” are used herein for literaryconvenience. The devices and methods of the subject invention can besuited for use with RGP and with hybrid contact lenses with a rigid orsemi-rigid center portion and a softer, more pliable outer ring portion.This does not preclude the embodiments herein, or variations thereof,being useful for other types of contact lenses.

The term “pull force” is used herein to refer to the force applied to asuction cup against any adherent force formed between said suction cup,and a surface, such as a contact lens. A pull force can be applied in adirection away from the concavity of the suction cup or away from thesurface to which the suction cup is attached. For example, as describedherein, a pull force is used to remove a contact lens from an eye. Alsoas used herein, the term “maximum pull force” is the force necessary toremove an over-sleeve from the end of an adjustment rod.

As used herein, the terms “longitude” or “longitudinal length” refer tothe longitudinal measurement or the distance extending along the longaxis. For example, the longitude or longitudinal length of a lensmanipulator is the di stance or direction between the proximal end tothe distal end.

Finally, reference is made throughout the application to the “proximalend” or “proximal direction” and “distal end” or “distal direction.” Asused herein, the proximal end or proximal direction is that end thatapproaches or comes nearest to the eye. For example, the suction cup isat the proximal end of the lens manipulator. Conversely, the distal endor distal direction of the device is that end which approaches or isnearest to the hand during use or furthest from the eye. For example,ergonomic structures, such as a handle, for holding the lens manipulatorwith the fingers or hand can be located at the distal end of the lensmanipulator. As further example, the rod opening can be at the distalend of an over-sleeve.

It is to be understood that the figures and descriptions of embodimentsof the present invention have been simplified to illustrate elementsthat are relevant for a clear understanding of the invention, whileeliminating, for purposes of clarity, other elements that may be wellknown. Those of ordinary skill in the art will recognize that otherelements may be desirable and/or required in order to implement thepresent invention. However, because such elements are well known in theart, and because they do not facilitate a better understanding of thepresent invention, a discussion of such elements is not provided herein.

The present invention is more particularly described in the followingexamples that are intended to be illustrative only because numerousmodifications and variations therein will be apparent to those skilledin the art. As used in the specification and in the claims, the singularfor “a,” “an” and “the” include plural referents unless the contextclearly dictates otherwise.

Reference will be made to the attached figures on which the samereference numerals are used throughout to indicate the same or similarcomponents. With reference to the attached Figures, which show certainembodiments of the subject invention, it can be seen that the subjectinvention, in general, comprises a lens manipulator 100 that includes anelongated over-sleeve 200 with a suction cup 220 at the proximal end 10and a lumen 224 through the longitudinal length 50. The lumen opens intoa pore 226 within the suction cup at the proximal end 10 and terminatesat the opposite distal end 20 in a rod opening 230. One embodimentincludes a plug having a nipple 717 that fits into the rod opening. Analternative embodiment, has an adjustment rod 300 with a proximal endthat is moveably inserted into the rod opening. The adjustment rod canbe moved into and out of the lumen to control the suction force that canbe generated under the suction cup. If the rod or nipple is removed fromthe lumen, the suction cup is inhibited from generating a suction force,which provides an advantageous safety release mechanism 700 to the lensmanipulator. Additional embodiments can include an outer cuff 500 thatgoes around or partially around the over-sleeve to provide controlledfriction against the over-sleeve being removed from the adjustment rod.The cuff can also be used as a control mechanism for adjusting thesuction force of the suction cup. An alternative embodiment has theproximal end components, including the proximal end of the adjustmentrod and over-sleeve angled relative to the ergonomic structures used tohold the lens manipulator. There are also disclosed embodiments of anover-sleeve with a suction cup having a peripheral edge 60 capable ofbeing deflected so that a continuous leading edge 80 can be used to forma vacuum with a contact lens 5. With these embodiments, there can alsobe a lumen 224 that traverses at least some portion of the stem andopens onto the suction cup as a pore 226. Each of these generalcomponents can have one or more sub-components, which will be discussedin detail below.

In FIG. 1 there is shown one embodiment of a lens manipulator and thevarious general, components thereof. In this embodiment, the over-sleeve200 has an elongated stem 210 that terminates in a suction cup 220 atthe proximal end 10. The suction cup can be formed as part of the stemto form the over-sleeve. Alternatively, the suction cup can be aseparate component that is operably attached to the stem to form theover-sleeve. In one embodiment, the suction cup is centered over theproximal end of the stem, such that the apex 222, or the point furthestfrom the peripheral edge 60 of the suction cup is aligned with thelongitude 50, such as shown, for example, in FIG. 2. In alternativeembodiments, the suction cup can be off-set, such that the apex isoff-center from the longitude. A person with skill in the art will beable to determine an appropriate off-set distance for the apex tofacilitate contact with a contact lens.

In another embodiment, the stem has a lumen 224 that extends the fulllongitudinal length 50 of the over-sleeve. In a further embodiment, theproximal end 10, the lumen can terminate within the concavity 221 of thesuction cup. In yet a further embodiment, the distal end 20, the lumencan terminate in a rod opening 230 into which the proximal end 10 of theadjustment rod 300 can be inserted. In a further embodiment, theproximal end of the lumen narrows at the pore 226, so that the diameterof the pore is less than the diameter of the lumen. An example of thisis shown in FIGS. 2 and 3A.

The suction force generated by a suction cup is caused by the differencein air pressure between the outside and inside of the cup and thesurface area of the object covered by the concavity 221 of the suctioncup. Changing one or both of these factors can affect the suction forceproduced by the suction cup. In one embodiment, the lumen 224 can beused to adjust the difference in air pressure between the outside andthe inside of the suction cup. By moving the adjustment rod into or outof the lumen, the air pressure that can be generated under the suctioncup can be altered, thus adjusting the release force to individual needsand preferences. In one embodiment, the diameter of the lumen is suchthat the adjustment rod is friction fit in the lumen, but can beslidably adjusted in the lumen to change the total volume of the lumenand the concavity 221 of the suction cup. In a further embodiment, theadjustment rod and the lumen form an airtight seal between them, so thatambient air is inhibited from entering the lumen from the rod opening230. Moving the rod into and out of the lumen to change the volumebetween the suction cup and the adjustment rod thereby changes or altersthe maximum suction force that can be formed by the suction cup with acontact lens. In one embodiment, the maximum suction force generated bya suction cup for attachment to a contact lens is at least 20 g, 25 g,30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g,90 g, 95 g, 100 g, 105 g, 110 g, 115 g, 120 g, 125 g, 130 g, 135 g, 140g, 145 g, 150 g, 155 g, 160 g, 165 g, 170 g, 175 g, 180 g, 185 g, 190 g,195 g, 200 g, or a suction within a range between any two of the listedvalues. In a specific embodiment, the maximum suction force allowed tobe generated between a contact lens surface and a suction cup of thesubject invention is approximately 115 grams.

The dimensions of an adjustment rod and lumen can depend upon a varietyof factors, including, but not limited to, the type of contact lens itwill be used with, the amount of force necessary to secure a contactlens for insertion and removal, the dimensions of the suction cup, andother factors understood by those with skill in the art. In oneembodiment, the lumen 224 has a longitudinal length 50 of betweenapproximately 5 mm and approximately 20 mm. In a more specificembodiment, the lumen has a longitudinal length of between approximately10 mm and approximately 15 mm. In another embodiment, the adjustment rod300 has a length of between approximately 5 mm and approximately 15 mm.In a more particular embodiment, the adjustment rod has a length ofbetween approximately 8 mm and approximately 13 mm. In a specificembodiment, the adjustment rod has a length of about 10 mm.

Suction cups typically have a continuous, pliant outer or peripheraledge 60 to create a seal against the surface of a contact lens 5, whichallows a vacuum to be formed under the suction cup when air is removedor forced out. While this can be advantageous when handling a lens forextraction, it can inhibit use of the suction cup for insertion, becauseof a slight suction force that can be formed when depositing the lensonto the eye surface. This small suction force can be sufficient toinhibit a successful insertion and release of the contact lens.

In an alternative embodiment of the subject invention, a suction cup 220can have various types of discontinuities 70 around the peripheral edge60. For example, the peripheral edge can have one or more lobes, petals,fingers, teeth, or be otherwise interrupted, serrated, indented, or haveany of a variety of uneven or non-uniform edge, such as shown, forexample, in FIGS. 15, 19A, 19B, 20, 21 and 22. In an alternativeembodiment, the discontinuities can be holes, fenestrations, openings orother types of vents 65 around the peripheral edge that allow air tocirculate into the suction cup when a contact lens is disposed on thediscontinuous peripheral edge, thereby inhibiting forming a seal whensmall forces act on the suction cup and when the peripheral edge is notdeflected or deformed. FIG. 16 illustrates a non-limiting example ofvents around the peripheral edge of a suction cup 220. Thediscontinuities 70 in the peripheral edge and/or vents can allow thesuction cup to support the weight of a contact lens and materials thatmay be deposited therein, such as, for example, saline solutions ormedicaments, while inhibiting the peripheral edge from forming suctionwith the contact lens, therefore allowing easier release of the contactlens 5A at the time of deposition on an eye.

In one embodiment, the convex side of a contact lens can be gentlyplaced on the discontinuities 70 around the peripheral edge 60, asshown, for example, in FIG. 19A, such that the peripheral edge isinhibited from being deformed or altered in shape. Thus, the peripheraledge 60 should have sufficient rigidity to support the weight of acontact lens and any fluids or materials in the concavity 221. Therigidity should allow the contact lens to rest on the peripheral edge ofthe discontinuities, so that there is minimal contact with the convexsurface 9 of the contact lens. FIG. 19A illustrates one example of thisarrangement of a contact lens on a plurality of discontinuities around aperipheral edge.

When the contact lens is placed on the cornea of the eye, the peripheraledge can be easily disengaged from the contact lens with minimal or noforce. As will be discussed below, the peripheral edge 60, whilesufficiently rigid to support a contact lens, can also have a “moment offlexion” or “bending moment” at which the rigidity of a discontinuity 70is overcome by applied forces and causes the peripheral edge to bedeformable or deflectable, such that it can be moved out of the way toexpose a continuous edge 80. Such moment of flexion or bending can be aninstantaneous or almost instantaneous reaction to applied force.Alternatively, it can be a gradual bending or deformation of thediscontinuities in response to applied forces.

Extraction of a contact lens with a suction cup usually necessitatesthat suction be formed between the outer convex surface 9 of a contactlens 5 and the inner concavity 221 of a suction cup. The methods forforming suction under a suction cup are known in the art. In oneembodiment, the discontinuities 70 arise from the continuous edge 80.For example, the discontinuities that form a peripheral edge andcontinuous edge can be formed from the same material, such that theperipheral edge and continuous edge are integral or continuous with eachother, such as shown, for example in FIG. 15. In an alternativeembodiment, the discontinuities arise from a different area or positionon the suction cup, such as next to or beside the continuous leadingedge. For example, the discontinuities can arise from around the outsideor convex surface of the suction cup and extend above the continuousleading edge 80, such as shown, for example, in FIG. 16. At the time ofextraction, the suction cup 220 can be pressed against the contact lenscausing the peripheral edge 60 to be deflected so that a leading edge 80there below can contact the convex surface 9 of the contact lens. Morespecifically, at the time of extraction the cup can be pressed againstthe contact lens such that the discontinuous peripheral edge isdeflected or pushed radially outward, away from the concave surface 7 ofthe contact lens, thereby exposing or otherwise allowing the leadingedge 80 to engage the contact lens, so that a seal can be created withthe smooth, uninterrupted, continuous leading edge of the suction cup.

The discontinuities 70 of a peripheral edge can be uniformly placed,such that there is an even pattern or distribution of the interruptedperipheral edge 60. FIGS. 15 and 16 illustrate one example of evenlyplaced discontinuities. In an alternative embodiment, thediscontinuities can be unevenly or randomly distributed around theperipheral edge 60 of the suction cup. For example, the discontinuitiescan be bunched or grouped in certain areas. In another alternative therecan be wider gaps or spreading between the discontinuities creating openareas. The arrangement of discontinuities to form a peripheral edge canbe determined by a person of skill in the art.

Contact lenses and in particular rigid contact lenses can be more easilyextracted when the extraction or pull force is applied eccentrically. Arandom distribution of discontinuities can assist with extraction orinsertion of contact lenses that benefit from eccentric positioning ofthe suction cup. Eccentric positioning means that the suction cup 220engages off-center with the convex surface 9 of a contact lens 5. Duringan eccentric extraction, a more open area of the peripheral edge 60 withfewer, gapped, or no discontinuities can be oriented towards theperiphery of the contact lens, so as to minimize contact with the sclerawhen discontinuities deflect. These same areas can also be beneficialwith video-assisted devices such as the CLIARA, disclosed in U.S.Published Application No. 2015/0265467, as the open areas do notinterfere with visualization of the contact lens.

Suction cups usually have a smooth surface to ensure an optimal seal isachieved. This smooth surface finish tends to be adherent or “sticky” tothe touch, which can be beneficial for contact lens 5 extractions, butcan be problematic for contact lens insertion. In one embodiment of thesubject invention, a portion of the concave surface 7 of a suction cupcan have a non-smooth surface and another portion can have a smoothsurface, such that the concave surface has two different surfacefinishes. With this embodiment, a peripheral band 72, around theproximal end 10 of the concave surface of the suction cup 220, can bestippled, roughened, ridged, or otherwise textured to provide anon-smooth or rough surface to the area of the peripheral band 72, whichcan form less adhesion to a contact lens convex surface. Further, withthis embodiment, there can also be a central region 74, on the concaveinterior distal 20 to the peripheral band that can stick or adhere tothe contact lens surface. The central region can be a smooth surface orcan be coated with something that imparts a “sticky” surface to adhereto the contact lens surface. FIG. 16 is an illustration of a suction cupembodiment having a peripheral band 72 and a central region 74. Acontact lens positioned against the textured peripheral band 72 of thesuction cup can be inhibited from adhering to the textured surface bythe inherent surface tension, thereby inhibiting the creation of suctionunder the suction cup. This can be advantageous when inserting a contactlens as the peripheral edge can release or disengage from the contactlens, therefore allowing a successful insertion.

When extracting a contact lens, the sticky central region 74 can becomebeneficial. The suction cup can be pushed or pressed onto the contactlens, so as to deflect or push aside the peripheral band 72, allowingthe contact lens to make contact with the central portion of the suctioncup. The central portion having a smooth edge can form a seal with theconvex contact lens surface, therefore forming suction that can alsopromote successful extraction.

Contact lenses, in particular rigid contact lenses, can be more easilyextracted when a force is applied eccentrically. Eccentric extractionforce means that the suction cup 220 engages the lens surface at anangle of incidence that is off-center of the contact lens. A contactlens is typically semi-spherical or partially hemispherical in shape.Therefore, an extraction with an off-center angle of incidence meansthat the suction cup is applied off center of the central axis of thecontact lens. The suction cup is applied towards one side of the lens,so that the leading edge can make full contact with the contact lens. Inone embodiment, the suction cup attached to a stem and used for manualcontact lens extraction has a substantially rigid or non-pliableconnection between the suction cup and the stem or handle. Whenperforming an eccentric extraction with manual lens manipulators 100,where the contact lens is conveyed to the eye by hand, the angle ofincidence of the cup can be manually adjusted, thereby achievingoff-center contact with the contact lens. However, when non-manual, lensmanipulators are used, such as the CLIARA device mentioned above, thesuction cup used therewith can have a fixed angle of incidence, relativeto the eye, and can approach from the front of eye. The angle ofincidence is usually centered on the contact lens, or is parallel to theoptical axis. Suction cups rigidly attached to a handle or stem caninhibit an eccentric extraction because the suction cup cannot tilt orbend sufficiently to make full contact with the side of the lens.

To facilitate bending or tilting of the suction cup 220 relative to thestem 210, there can be a flexible connector 150 between the suction cup220 and the stem 210, The flexible connector can be sufficiently stiffor rigid to hold the suction cup in position for a linear approach to acontact lens and still be able to flex or bend to facilitate aneccentric connection to the contact lens. In a particular embodiment,the flexible connector has a bendable neck. In a further embodiment, thebendable neck utilizes a bellows-type configuration, such as shown, forexample, in FIG. 17. Bellows-type connectors have thinner or narrowerareas that provide flexure and thicker or wider areas that inhibitover-flexing and help maintain torsion control. Bellows connectors areknown in the art and any of a variety of styles or configurations can beused with the embodiments of the subject invention. As will be discussedbelow, bellows-type connectors can be advantageous for a stem having acentral channel and can inhibit the interior lumen from collapsing underbending loads and/or vacuum pressures.

Another characteristic of suction cups is that they can generate an evenor uniform suction around the circumference of the suction cup whenattached to a contact lens. This is due to the rotationally symmetricdesigns, and a theoretical axial pull that deforms the cup uniformly.Thus, deforming the circumference of the suction cup can degenerate theuniformity of the connection and release the vacuum. Likewise, softcontact lenses can be more effectively released from the eye by not onlypulling the lens perpendicular to the eye, but also by pinching thelens, so as to deform the shape and allow air to enter the eye-lensinterface and break suction force between the eye and lens.

When utilizing a suction cup to remove a contact lens, it can bedifficult to engender a pinching or deforming action with the operationof the suction cup. To mimic the pinching effect, the force applied tothe peripheral edge 60 of the suction cup by the pull force or axialload can be applied in a non-uniform manner. This can encourage areas ofdifferent pliability on the peripheral edge 60 of the suction cup todeform in stages or at different times, as the pull force is applied tothe suction cup. More pliable areas of the suction cup can deform,causing them to pull against other less pliable areas, which deforms theperipheral edge and can promote the ingress of air between the eye andcontact lens interface.

In one embodiment, the suction cup has one or more areas that are rigid,less pliable, non-flexible, or otherwise inhibit the peripheral edge inthose areas from deforming when pull force is applied to the suctioncup. When a pull force is applied, usually with the stem 210 attached tothe center of the suction cup, the center of the suction cup is pulledaway from the contact lens, consequently elongating the suction cup. Thenon-pliable areas of the suction cup and peripheral edge can be deformedand pulled away from the contact lens first, thereby forming a pucker orfold in the contact lens that allows ingress of air between the eye andcontact lens interface.

In a further embodiment, there are one or more rigid sections on thesuction cup. The rigid sections can be in the form of radial ribs 92that extend along the outside surface 90, to create an intentionaluneven deformation of the cup upon application of pull force. In oneembodiment, there are two radial ribs positioned approximately 180degrees apart. The areas of the suction cup that are supported by theradial ribs will be inhibited from deforming or will deform less thanother areas of the suction cup. Upon application of pull force, thesuction cup will try to elongate and the peripheral edge of the suctioncup can experience an inward radial force pulling towards the center.The radial rib supported areas will have more resistance to this forcecompared to the un-supported areas. Therefore the opposing unsupportedregions will be drawn inward, generating a biased deformation of theperipheral edge 60, which will help create a pinching, folding, orpuckering action. Continued pulling can cause the areas supported byradial ribs to disengage from the surface first, since they can be lessprone to deforming and being drawn into the center of the suction cup.When these areas disengage, air can enter under the suction cup andbreak the suction.

A contact lens can form a strong adherence to the surface of the eye.This can be beneficial when wearing the contact lens. However, whenremoving the contact lens, such strong adherence can inhibit the removalof the contact lens. Unfortunately, it is not always possible to know inadvance if a contact lens has formed a particularly strong adherence tothe eye. When the suction cup 220 is placed against the contact lens onan eye, the suction cup can be pushed against the contact lens to formthe suction force, by forcing air out of the concavity 221 under thesuction cup. Once this suction force is generated, it can be difficultto remove the suction cup from the contact lens without applying asignificant, and potentially harmful, amount of pull force against thesuction cup which is therefore transmitted to the surface of the eye.

Embodiments of the subject invention can provide an advantageous safetymechanism by which the suction cup can be removed without application ofan excessive amount of pull force against the contact lens. In oneembodiment, a friction fit between the adjustment rod 300 and the lumen224 is configured to cause the adjustment rod to be removed from thelumen if a pre-determined amount of pull force is applied to the lensmanipulator. When the adjustment rod is pulled from the lumen, the lumenvolume fills with ambient air, thereby equilibrating the externalpressure and the internal pressure of the suction cup. This eliminatesthe suction force on the contact lens, so that the now stand-aloneover-sleeve can be manually removed or may self-release from the contactlens. In one embodiment, the diameter of the adjustment rod is at least0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm,1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm,2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm,3.4 mm, and 3.5 mm, or a diameter that is a range between any two of thelisted values.

Once the over-sleeve has been removed, the rod can be reinserted intothe rod opening to, again, be used to adjust the volume of the lumen. Inone embodiment, the distal end of the rod opening 230 has a bevel orchamfer 232 around it to aid in insertion of the adjustment rod. FIGS. 2and 3A illustrate an example of a rod opening with a chamfered edge.

As mentioned above, the ability to remove the adjustment rod 300 fromthe lumen 224 can provide an advantageous safety mechanism for releasingthe suction force in the suction cup, thereby preventing undesirable orexcessive pulling force on the eye and/or contact lens thereon. In orderto ensure quick release of the suction force, the adjustment rod can beinserted into the lumen a sufficient distance to block the lumen andallow the suction force to be formed, but not so great a distance thatit cannot be quickly removed to release the suction. FIG. 4 illustratesan example of an adjustment rod inserted into the lumen a sufficientdistance to allow suction to be formed and still be quickly removed fromthe lumen.

Depending upon the dimensions and configuration of the over-sleeve, anadjustment rod can fill a small portion, for example, less than 50%, ofthe volume of the lumen 224. The remaining open space of the lumen cancause more suction force than necessary to be formed under the suctioncup. In one embodiment, the proximal end 10 of the adjustment rod can beconfigured with a spacer 320 to reduce the volume of the lumen, withouthaving to insert the rod further into the lumen. A spacer can be anarrower extension from the proximal end 10 of the adjustment rod. FIG.3A illustrates one example of a spacer that is narrower than theadjustment rod and juts from the proximal end of the adjustment rod.FIG. 3B illustrates another example of a spacer that is a conicalextension at the proximal end of the adjustment rod. Otherconfigurations of spacers are possible and within the scope of thisinvention. The use of a spacer on an adjustment rod allows theadjustment rod to be inserted as far as necessary to block air flow, bequickly removed, while the remaining volume is reduced to control themaximum suction force that can be formed under the suction cup.

A further advantage of a spacer is that it permits a user to pull theadjustment rod out of the lumen just far enough to allow the ingress ofambient air into the lumen, leaving the spacer in the lumen. This allowsthe user to replace the adjustment rod in the lumen more easily and, ifnecessary, without seeing the rod opening, since the spacer can maintainalignment of the adjustment rod and lumen.

The dimensions of a spacer can vary, depending upon the longitudinallength of the lumen 224, the length of the adjustment rod, and how muchof the adjustment rod is inserted into the lumen. In one embodiment, thedimensions of a spacer are such that, when the adjustment rod ispositioned within the lumen, the spacer reduces the remaining volume inthe lumen by between approximately 25% and approximately 85%. In afurther embodiment, the dimensions of a spacer are such that, when theadjustment rod is positioned within the lumen, the spacer reduces theremaining volume in the lumen by between approximately 35% andapproximately 75%. In a more specific embodiment, the dimensions of aspacer are such that, when the adjustment rod is positioned within thelumen, the spacer reduces the remaining volume in the lumen by betweenapproximately 45% and approximately 65%. In a specific embodiment, whenthe adjustment rod is positioned within the lumen, the spacer reducesthe remaining volume in the lumen by approximately 50%.

The overall length of an over-sleeve can depend upon the required lengthof the lumen, the dimensions of the suction cup, the length of the stem,and other factors known to those having skill in the art. In oneembodiment, the overall length of an over-sleeve is betweenapproximately 20 mm and approximately 60 mm. In a specific embodiment,the overall length of an over-sleeve is approximately 25 mm.

Once it has been determined how much of the length of the adjustment rod300 should extend into the lumen, to provide the desired maximum suctionforce, it can be beneficial for that specific length to be set or fixedfor the lens manipulator during use. In one embodiment, there can bevisual indicators 330 on the rod that can be used to determine how muchof the adjustment rod extends into the lumen. For example, graduatedmarks on the adjustment rod can be used to check the amount ofadjustment rod in the lumen. FIG. 2 illustrates a non-limiting exampleof visual indicators. A friction fit between the adjustment rod andlumen can aid in maintaining the length where indicated.

FIGS. 2 and 4 illustrate embodiments where the adjustment rod andover-sleeve are collinear with the longitudinal length 50 of a lensmanipulator 100. These embodiments allow the lens manipulator to be heldsubstantially vertical or perpendicular to the ground, with the suctioncup of the over-sleeve directed upwards for use. In use, the lensmanipulator can be held in one hand in front of the body. By bendingforward, towards the hand holding the lens manipulator, the eye can bebrought into proximity with the suction cup to install or remove acontact lens on the eye.

FIGS. 8-14 illustrate an alternative embodiment where a portion 310 ofthe proximal end 10 of the adjustment rod 300 is bent, turned, orotherwise angled away, relative to the distal end 20 of the adjustmentrod. Thus, an over-sleeve 200, when positioned over the adjustment rod300 can be non-collinear with the longitude 50 of the lens manipulator.With this embodiment, the distal end 20 of the lens manipulator can beheld so that the hand holding the lens manipulator is at least partiallyout of the line of sight when the suction cup is directed upwards foruse. This arrangement is ergonomically advantageous and inhibits thehand from interfering with viewing the suction cup as the eyeapproaches. It also allows one or more fingers on the same hand thatholds the lens manipulator to be used for pulling an eyelid away fromthe eye while simultaneously advancing the contact lens towards the eye.Thus, both hands are not required to be used for moving the eyelid andholding the lens manipulator.

In one embodiment, the bent portion 310 at the proximal end of theadjustment rod has an angle (e) of between approximately 10° andapproximately 120° relative to the longitudinal length or the distal endof the adjustment rod as demonstrated in FIGS. 8 and 11. In a moreparticular embodiment, the bent portion at the proximal end of theadjustment rod has an angle of between approximately 30° andapproximately 110° relative to the longitudinal length or the distal endof the adjustment rod. In specific embodiment, the bent portion at theproximal end of the adjustment rod has an angle of between approximately80° and approximately 100° relative to the longitudinal length or thedistal end of the adjustment rod. In a specific embodiment, the bentportion at the proximal end of the adjustment rod has an angle ofapproximately 90° relative to the longitudinal length or the distal endof the adjustment rod. One non-limiting example of this specificembodiment is shown in FIG. 12.

In an alternative embodiment, a tensioning sleeve 400 can be used on theadjustment rod 300. In one embodiment, the tensioning sleeve is agenerally elongate structure that has a bore 410. In one embodiment, thebore opens onto and forms an aperture 415 at the proximal end 10. Therecan also be an exit 420 on the distal end 20. The adjustment rod can befrictionally fit into the tensioning sleeve. By moving the adjustmentrod into and out of the aperture, the length of the adjustment rod thatextends into the lumen can be adjusted. When the over-sleeve ispositioned on the proximal end of the adjustment rod, the distal end ofthe over-sleeve can abut against the proximal end of the tensioningsleeve. Thus, only the length of adjustment rod that extends from theaperture will extend into the lumen of the over-sleeve. FIG. 2illustrates a non-limiting example of a tensioning sleeve with anadjustment rod extending from the aperture. FIGS. 3A and 4 illustratenon-limiting examples of the over-sleeve sitting on an adjustment rodand abutting the proximal end of the tensioning sleeve.

The frictional fit of the over-sleeve 200 on the adjustment rod 300 candetermine the maximum amount of force necessary to pull the rod from thelumen 224. The ability to remove the adjustment rod from the lumenprovides an advantageous safety mechanism 700 to prevent excessive andundesirable pulling force being applied to the eye. As discussed above,in one embodiment the rod and the lumen form a friction fit thatreleases upon application of a pre-determined amount of pull force.

In another embodiment, a cuff 500 can be used to provide a frictionalfit with the over-sleeve. A cuff can be a tubular shape, as shown, forexample, in FIGS. 1 and 2, that surrounds a proximal portion of thetensioning sleeve 400 to form a seat 510 around the over-sleeve. In oneembodiment, the cuff makes at least partial contact with the over-sleevepositioned in the seat, such as shown, for example, in FIGS. 3A and 4.The cuff can provide resistance to the over-sleeve being lifted off ofthe adjustment rod. The seat formed by the cuff can also act as a guidefor reattaching or reseating the over-sleeve on the adjustment rod.FIGS. 5A and 6 illustrate an alternative embodiment of a cuff that isintegral with or formed as part of the tensioning sleeve.

The cuff 500 and the over-sleeve 200 can also be configured to controlthe amount of suction force formable under the suction cup and also actas a safety mechanism 700. In one embodiment, the stem 210, or at leasta portion thereof, when positioned in the proximal end 10 of the bore510 forms an air tight seal 530 with the cuff. As described above, thesuction cup 220 of the over-sleeve 200 can be pushed against a contactlens 5. The air-tight seal permits suction to be created between thetwo. In a further embodiment, a plunger 800 is disposed at the distalend 20 of the cuff. FIG. 23A illustrates a non-limiting example of thisembodiment. The suction that can be formed can be adjusted by how farinto the bore 510 of the cuff 500 the over-sleeve 200 is pushed. In FIG.23A, the over-sleeve is shown positioned against the proximal end 10 ofthe plunger 800, which can provide the strongest suction force. FIG. 23Bshows the over-sleeve distanced from the proximal end of the plunger,which leaves an air-filled void 540 between the plunger and theover-sleeve. This air-filled void can reduce the amount of suction forceformable between the suction cup and a contact lens. Changing the volumeof the void can change the amount of formable suction. In the event thatthe contact lens and the suction cup form too strong a suction, asdiscussed above, the plunger can be used as a safety mechanism 700 topush the over-sleeve out of the proximal end 10 of the bore 510. Whenthe suction cup exits the bore, the air-tight seal 530 breaks, therebyallowing air into the lumen and eliminating the suction force betweenthe contact lens and the suction cup.

Embodiments having an over-sleeve and adjustment rod that are collinearwith the longitude of the lens manipulator, such as shown, for examplein FIGS. 1, 3A, 4, 5A, and 6, can also have a cuff that is collinearwith the longitude, as shown in FIGS. 2 and 4. Where the adjustment rodhas a bent portion 310, the cuff 500 can be rotated relative to thelongitude 50, so as to engage with the over-sleeve positioned over thebent portion. FIGS. 9, 10, and 11 illustrate an example of an embodimentwith the rotated cuff rotated. With this embodiment, the cuff can bepositioned at the same angle as the bent portion 310 and theover-sleeve, so as to be collinear with these components.

In one embodiment, the cuff is slidably engaged with one or morecomponents of the lens manipulator. For example, the cuff 500 can have aC-shaped circumference, as shown in FIGS. 13 and 15, which allows thecuff to slide over the non-bent portion of the adjustment rod or atensioning sleeve. In the example shown in FIGS. 13 and 15, the cuff isslidably engaged with an ergonomic feature 600, here shown as a handle.Any of a variety of techniques and devices can be used to slidablyengage the cuff with the lens manipulator components. FIGS. 13 and 14illustrate an embodiment that uses a tongue 520 and groove 525arrangement. Alternatively, the rotated cuff can be formed or integratedwith the lens manipulator and fixed in place.

In yet another embodiment, the adjustment rod 300 can have a detent 340or enlarged or flared portion at or at about the proximal end 10. Thedetent can engage with the lumen in the over-sleeve 200. A detent canprovide a frictional fit or resistance that inhibits the over-sleevefrom being removed from the adjustable rod until or unless apre-determined amount of pull force is applied to the over-sleeve. In afurther embodiment, the lumen can be configured with a length thatprovides the necessary resistance under normal use and allows theover-sleeve to come off the adjustment rod if an excessive pull force isapplied to the suction cup. A detent can be any of a variety of surfacefeatures or apparatuses that push against or otherwise engage with thewall of the lumen. For example, a flare or detent can be a barb thatprotrudes outward from the side of the adjustment rod, such as shown inFIG. 5C. By way of another example, a detent can be a spring-loaded ballthat retracts into the adjustment rod. Spring-loaded balls used forengaging two objects are well-known in the art and, thus, have not beenshown.

Specific frictional forces and/or resistance forces are necessary tomaintain the over-sleeve on the adjustment rod during normal use andprovide a safety release that allows the over-sleeve to be disengagedfrom the adjustment rod under certain conditions. The embodimentsdisclosed herein provide several devices and techniques for configuringand adjusting one or more of these forces. These techniques and devicescan be used singularly or in combination.

FIGS. 5A, 5B and 5C illustrate an embodiment that utilizes all of thedevices and techniques described herein. FIG. 5A shows an embodiment ofa fully assembled lens manipulator that has a tensioning sleeve 400 witha cuff 500 formed at the end of the tensioning sleeve in which anover-sleeve is disposed. FIG. 5B is a partially disassembled view thatshows the adjustment rod 300 with the over-sleeve on the proximal end10. FIG. 5C shows the adjustment rod with the detent at the proximal endthat can be used to provide resistance to hold the over-sleeve on theproximal end. With this embodiment, the lumen of the over-sleeve can beconfigured with a length and diameter that provide sufficient resistanceduring normal use, but provide a safety release that operates whenexcessive pull force is applied to the suction cup. Other embodimentscan use various combinations of a cuff, adjustment rod, lumen in theover-sleeve, and a detent to achieve the desired frictional andresistance forces.

The embodiments of the subject invention can be used manually. FIG. 7illustrates how the fingers and palm can be used to hold and control thelens manipulator. In one embodiment, the fingers on one hand can be usedto remove the over-sleeve from the adjustment rod, should the safetyrelease not be sufficient. There can be various ergonomic structures 600on the lens manipulator to assist with holding and manipulating theover-sleeve. FIGS. 5A, 5B, and 5C illustrate an enlarged handle at thedistal end 20 of an adjustment rod that can be held in the palm. FIG. 6illustrates ribbing on the external surface of the cuff and thetensioning sleeve that can assist with holding the lens manipulator.FIG. 7 illustrates a lens manipulator made of a material that formsstiction with fingers. FIGS. 8, 9, and 10 illustrate examples of ahandle having an ergonomic curvature that aids in holding andmanipulating the position of the over-sleeve and suction cup. It can beadvantageous if the ergonomic features 600 allow the lens manipulator tobe held in one hand. It can be further advantageous if the ergonomicfeatures allow the lens manipulator to be held such that at least one,preferably two, fingers of the holding hand are free to move theeyelid(s) away from the eye during use of the lens manipulator. Forexample, ergonomic structures or design can allow the lens manipulatorto be held with the thumb and forefinger, thus leaving at least thesecond and third fingers free to extend forward and move the lowereyelid downward, while the suction cup simultaneously advances towardsthe eye. Other ergonomic structures that provide the same or similarbenefits are within the scope of the subject invention.

The over-sleeves of the subject invention can be stand-alone elementswhere a passive vacuum is created and maintained by displacement of airunder the suction cup, such as, for example, by the deformation of thesuction cup. An over-sleeve 200 of the subject invention can be adaptedfor use with a lens manipulator that utilizes an active vacuum, wherevacuum is generated and maintained by active displacement of air underthe suction cup with another device, such as a pump or other activesuction component. Generation of an active vacuum under the suction cupcan necessitate a communication between an active suction component 25,such as, for example, a pump or negative pressure-forming pliable bulb,and the suction cup.

In one embodiment, an over-sleeve 200 of the subject invention has alumen 224 that extends through the stem 210 and onto the concave surface7 of the suction cup to form a pore 226 on the concave surface. Thus,the lumen communicates a rod opening 230 at the distal end 20 of thestem 210 with the pore 226 on the concave surface of the suction cup220. FIGS. 15-18B and 20 illustrate non-limiting examples ofover-sleeves 200 adapted with lumens 200. The lumen can be used tocooperatively engage with a suction component 25 of a lens manipulator,as shown, by way of example, in FIG. 20. In one embodiment, the pump orother active vacuum component 25 cooperatively engages with the rodopening 230 of the over-sleeve 200, which communicates with the pore 226of the suction cup, located at the suction cup concave surface, whichcomes in contact with the contact lens. This lumen allows an over-sleeveto be used with active vacuum components, such as peristaltic pumpseither with negative or positive pressure.

As mentioned above, during extraction of a contact lens, the contactlens can be inhibited from being removed from the eye. This can becaused by a variety of reasons, such as, for example, formation of toostrong a suction, insufficient fluid between the contact lens and of theeye, or other phenomenon. Usually, the inability to remove the contactlens is not determined until after a vacuum seal has been formed betweenthe contact lens and the suction cup of an over-sleeve. The lumen can beused as a safety mechanism 700 by which the vacuum formed between thecontact lens and suction cup can be released or “broken.”

In one embodiment, a safety mechanism 700 can include plug 715 that canbe used to block the distal end opening 210 of a lumen 224. The plug canbe disposed at the distal end of the stem with a friction fit. The forceof the friction fit can be specifically configured to inhibit air frommoving through the lumen, but allow the over-sleeve to be or removedfrom the plug by the force of trying to remove the suction cup and aresistant contact lens.

In one embodiment, the plug 715 has a nipple 717 that can be frictionfit into the distal end opening 210. The friction fit can be sufficientto hold the river-sleeve 200 in place regardless of the vertical orhorizontal orientation. FIGS. 20 and 21 illustrate non-limiting examplesof a safety mechanism 700 having plugs 715 with nipples 717 that can befit into the distal end opening 210 of a lumen 224.

In another embodiment, the plug 715 has a skirt 330 around the proximalend 10 into which the distal end 20 of the stem 210 can be inserted.Thus, the skirt can surround the distal end of the stem 210 of theover-sleeve 200. The skirt can form a friction fit with the plug to holdthe over-sleeve in place regardless of the vertical or horizontalorientation. FIG. 20 illustrates a non-limiting embodiment of a plug 715having a skirt 730 that can surround the distal end of a stem.

The plug can be held manually or attached to a lens manipulator 100. Thesuction cup of an over-sleeve can be used to form a vacuum with acontact lens. As an axial load is applied to the contact lens with theover-sleeve, the friction fit holds the plug and the over-sleevetogether as the contact lens is removed. If the axial load exceeds apre-determined threshold, whereby the contact lens will not release fromthe eye, the force of the friction fit can be overcome causing the plugto disengage from the channel. This allows air or other gases to moveinto the channel and the suction cup, thereby releasing the vacuum forcebetween the contact lens and the suction cup.

A lens manipulator 100 can include a pump 25 for generating a vacuumbetween the suction cup and a contact lens. As described above,embodiments of an over-sleeve 200 can have a lumen 224 that can beoperatively connected to a pump, as illustrated, for example, in FIG.22. An over-sleeve of the subject invention that employs a safetymechanism 700 can also be utilized with a lens manipulator. In oneembodiment, the plug can have a co-lumen 720. When the over-sleeve isfriction fit with the plug, as described above, the lumen 224 and theco-lumen 720 can be integral or continuous with each other. When theover-sleeve and safety mechanism are utilized with a lens manipulator100, the lumen 224 can be operatively connected to the co-lumen 720,which can be operatively connected to a pump, as demonstrated in FIG.22. When the suction cup is applied to the contact lens, the pump cangenerate a vacuum by pulling air through the lumen and the co-lumen.

Advantageously, the safety mechanism can also operate with a lensmanipulator 100. As described above, if the axial load applied to removea contact lens exceeds a certain, pre-determined threshold, the plug candisengage from the stem, separating the lumen from the co-lumen, therebybreaking the vacuum formed by the pump. Even if the pump is configuredto emit air into the suction cup to break a vacuum seal, it can beadvantageous for the over-sleeve to be removable from the plug, so thatthe contact lens can be further manipulated away from the lensmanipulator.

Lens manipulators 100 can have visual indicators 330 that assist inguiding and aligning the eye with the suction cup during handling of acontact lens. By looking at the indicator 330 as the suction cupapproaches the eye, the contact lens and/or suction cup can be centeredon the cornea. Alternatively, looking away from or sideways to theindicator 330 can facilitate an eccentric contact lens removal,described above.

In one embodiment, the indicator is centered in the concave surface 7 ofa contact lens. In a further embodiment, the indicator is a light orlight-guide directed through a lumen 224, such that the light can beseen through the pore 205 of the lumen. For example, a light generatingmechanism can be placed at the distal end of the lumen. A lightgenerating mechanism can be an electrical apparatus that has a lightbulb. Alternatively, a light generating mechanism can be a fiber opticmaterial capable of transmitting light into the lumen.

In a particular embodiment, a plug 315 can be a light generatingmechanism, such that the plug has a dual function as part of a safetymechanism 700 and as an indicator 330. In one embodiment, shown, forexample, in FIG. 21, a plug can be formed of a light transmittingmaterial. When the plug is coupled to the stem, the light of the plug istransmitted into the lumen 224. The plug can function as describedabove. In a further embodiment, the plug can be operatively connected toa lens manipulator 100 that generates the light transmitted through theplug, which is shown by way of example, in FIG. 21.

Placement and removal of a contact lens from the eye can be difficultfor some patients. Rigid Gas Permeable lenses and hybrid lenses canprovide a particular challenge because of their size and uniquehard/soft configurations. The application of medicaments or othersubstances to the eye can also be challenging. The embodiments of thesubject invention provide devices that make the insertion and removal ofthese types of lenses and the application of substances to the eyeeasier, safer, and minimize the possibility of damage to the eye. A lensmanipulator of the subject invention can be configured with sufficientsuction force to hold a contact lens in place, on the suction cup,during insertion and still release from the contact lens afterinsertion. A lens manipulator of the subject invention can also includea safety release feature that releases the suction cup from the contactlens if the contact lens cannot be removed from the eye or if thesuction cup cannot be removed from the contact lens.

All patents, patent applications, provisional applications, and otherpublications referred to or cited herein are incorporated by referencein their entirety, including all figures and tables, to the extent theyare not inconsistent with the explicit teachings of this specification.Additionally, the entire contents of the references cited within thereferences cited herein are also entirely incorporated by reference.

The examples and embodiments described herein are for illustrativepurposes only and that various modifications or changes in light thereofwill be suggested to persons skilled in the art and are to be includedwithin the spirit and purview of this application.

Any reference in this specification to “one embodiment,” “anembodiment,” “example embodiment,” “further embodiment,” “alternativeembodiment,” etc., is for literary convenience. The implication is thatany particular feature, structure, or characteristic described inconnection with such an embodiment is included in at least oneembodiment of the invention. The appearance of such phrases in variousplaces in the specification does not necessarily refer to the sameembodiment. In addition, any elements or limitations of any invention orembodiment thereof disclosed herein can be combined with any and/or allother elements or limitations (individually or in any combination) orany other invention or embodiment thereof disclosed herein, and all suchcombinations are contemplated with the scope of the invention withoutlimitation thereto.

What is claimed is:
 1. An over-sleeve, configured to manipulate acontact lens, comprising: a stem having a proximal end and a distal endand a lumen therethrough that forms a port at the proximal end and a rodopening at the distal end; a suction cup, at the proximal end of thestem, comprising a leading edge; and a discontinuity extending from theleading edge and forming a discontinuous peripheral edge that can bedeflected upon an application of a force thereon.
 2. The over-sleeveaccording to claim 1, wherein the discontinuity forms an uneven ornon-uniform peripheral edge.
 3. The over-sleeve according to claim 2,wherein the discontinuity comprises at least one of a lobe, petal,finger, tooth, and serration on the leading edge that forms a peripheraledge.
 4. The over-sleeve according to claim 1, wherein the discontinuitycomprises a vent in the peripheral edge.
 5. The over-sleeve according toclaim 1, wherein the discontinuity comprises a peripheral band around atleast a portion of the peripheral edge.
 6. The over-sleeve according toclaim 1, further comprising a flexible connector between the suction cupand the stem.
 7. The over-sleeve according to claim 1, furthercomprising at least one radial rib arranged between the leading edge andat least a portion of the stem.
 8. A method for manipulating a contactlens comprising: obtaining an over-sleeve according to claim 1;arranging the lumen of the over-sleeve on an adjustment rod; placing acontact lens with a convex surface in contact with the discontinuity;moving the contact lens on the discontinuity towards an eye until thecontact lens is deposited onto the eye; and moving the over-sleeve awayfrom the eye, such that the contact lens remains on the eye.
 9. Themethod according to claim 8, further comprising: moving the over-sleevetowards the contact lens on the eye until the discontinuity touches thecontact lens; applying sufficient force to the over-sleeve to cause thediscontinuity to deflect and allow the leading edge to contact thecontact lens; applying sufficient additional force to the over-sleeve tocreate suction between the suction cup and the contact lens; and movingthe over-sleeve away from the eye, thereby removing the contact lensfrom the eye.
 10. The method according to claim 9, wherein thediscontinuity comprises at least one of a lobe, petal, finger, tooth,and serration on the leading edge that forms a peripheral edge.
 11. Themethod according to claim 9, wherein the discontinuity comprises a ventin the peripheral edge.
 12. The method according to claim 9, wherein thediscontinuity comprises a peripheral band around at least a portion ofthe peripheral edge.
 13. The method according to claim 9, wherein theover-sleeve comprises a flexible connector between the suction cup andthe stem; and the method further comprises moving the over-sleevetowards the contact lens so that the leading edge makes an eccentricconnection with the contact lens.
 14. An over-sleeve, configured tomanipulate a contact lens, comprising: a stem having a proximal end anda distal end and a lumen therethrough that forms a port at the proximalend and a rod opening at the distal end; a suction cup, at the proximalend of the stem, comprising a leading edge; and one or more rigidsections between the leading edge and at least a proximal portion of thestem.
 15. The over-sleeve according to claim 14, wherein at least one ofthe rigid sections comprises a radial rib.
 16. The over-sleeve accordingto claim 15, comprising at least two rigid sections arrangedapproximately 180° apart.
 17. A method for manipulating a contact lenscomprising: obtaining an over-sleeve according to claim 14; arrangingthe lumen of the over-sleeve on an adjustment rod; placing a contactlens with a convex surface in contact with the leading edge; moving thecontact lens on the leading edge towards an eye until the contact lensis deposited onto the eye; and moving the over-sleeve away from the eye,such that the contact lens remains on the eye.
 18. The method accordingto claim 17, further comprising: moving the over-sleeve towards thecontact lens on the eye until the leading edge touches the contact lens;applying sufficient force to the over-sleeve to create suction betweenthe suction cup and the contact lens; and moving the over-sleeve and thecontact lens away from the eye.
 19. The method according to claim 18,further comprising: moving the over-sleeve away from the eye until theone or more rigid sections create an intentional uneven deformation ofthe suction cup that allows air between the suction cup and the contactlens to break the suction therebetween.